(81 days)
IPS 99 One is a one-layer veneering ceramic for the fabrication of metal-ceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ªK (26.50°C)
IPS 99 Ceram is a conventional multi-layer veneering ceramic for the fabrication of metalceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ª/K (25-600°C).
IPS 99 is intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns.
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This looks like a 510(k) clearance letter for a dental ceramic product, not a study report for a medical device with performance metrics. Therefore, the requested information about acceptance criteria, study data, ground truth establishment, and expert involvement cannot be extracted from this document.
The document states that the "IPS 99 One and IPS 99 Ceram" are "Porcelain Powder for Clinical Use" and are "intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns." The letter confirms substantial equivalence to predicate devices, meaning it meets the regulatory requirements for marketing, but it does not include performance data or studies against specific acceptance criteria in the way a diagnostic or AI-powered device submission would.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.